Single-insertion, multiple sampling biopsy device with linear drive

ABSTRACT

A single-insertion, multiple sampling biopsy device for insertion into a host includes an outer cutting cannula that has an inner lumen, a cutting distal end, and a proximal sample receiving port. The device includes a stylet extending at least partially within the inner lumen of the outer cutting cannula and along a longitudinal axis of the outer cutting cannula. A sheath extends at least partially within the inner lumen of the outer cutting cannula. A stylet tip is attached to a stylet rail. Each of the sheath and the stylet rail extends along the longitudinal axis. The stylet tip extends in the distal direction beyond the distal end of the outer cutting cannula. A drive unit is configured to translate each of the cutting cannula, the sheath, and the stylet relative to the stylet tip in proximal and distal directions. The stylet rail remains stationary relative to the drive unit.

PRIORITY DATA AND INCORPORATION BY REFERENCE

This application is a continuation of application Ser. No. 16/003,877filed Jun. 8, 2018, now U.S. Pat. No. 11,219,431, which is acontinuation of U.S. patent application Ser. No. 14/318,081, filed Jun.27, 2014, now U.S. Pat. No. 10,010,307, which is a continuation of U.S.patent application Ser. No. 13/592,062, filed Aug. 22, 2012, now U.S.Pat. No. 8,771,200, which is a divisional of U.S. patent applicationSer. No. 11/997,403, filed Jul. 7, 2008, now U.S. Pat. No. 8,262,585,which is a U.S. national phase of International Application No.PCT/US2006/031325, filed Aug. 10, 2006, which claims benefit of priorityto U.S. Provisional Patent Application Ser. No. 60/707,289 filed Aug.10, 2005, each of which is incorporated by reference in its entirety.

FIELD OF THE INVENTION

This invention relates to a tissue biopsy sampling device.

BACKGROUND OF THE INVENTION

It is sometimes desirable or necessary to obtain specimens of tissuefrom humans and other animals, particularly in the diagnosis andtreatment of patients with cancerous tumors, premalignant conditions,and other diseases or disorders. For example, when it is discovered thatsuspicious conditions exist, either by means of x-ray or ultrasoundimaging in various tissues of the body, a physician usually performs abiopsy to determine if the cells at the suspected site are cancerous orbenign.

A biopsy can be done either by an open or percutaneous technique. Openbiopsy is an invasive procedure using a scalpel, by either a portion(incisional biopsy) being removed or the entire mass (excisional biopsy)is removed. Percutaneous biopsy is usually done with a needle-likeinstrument through a relatively small incision, and can be performed byfine needle aspiration (FNA) or through the taking of a core biopsysample. In FNA biopsy, individual cells or clusters of cells areobtained for cytologic examination and can be prepared such as in aPapanicolaou smear. In a core biopsy, a core or fragment of the tissueis obtained for histologic examination.

Uncontaminated and intact tissue from the organ, lesion, or tumor ispreferred by medical personnel in order to arrive at a definitivediagnosis regarding the patient's condition. In most cases only part ofthe tissue in question needs to be sampled. The portions of tissueextracted must be indicative of the organ, lesion, or tumor as a whole.Often, multiple tissue samples from various locations of the mass beingsampled may be taken.

The percutaneous biopsy procedure can be performed utilizing varioustechniques and devices. One such biopsy device can include an innerstylet positioned inside an outer cannula, where the stylet is able toslide into and out of the cannula. The stylet can be a solid, pointedneedle having a tissue sampling recess, and the cannula can be a hollow,open-ended needle having a sharp tip. The stylet and cannula can bemanipulated cooperatively to capture a tissue sample in the samplerecess. Such existing devices can be manually operated, semi-automated,and automated.

U.S. Pat. No. 6,485,436 shows a multiple sample biopsy needle with ahydraulic mechanism that circulates fluid from the tip of the needleback to a receiving basket or baskets. A revolver-type array ofreceiving chambers is disclosed.

U.S. Pat. No. 5,827,305 shows a tissue sampling needle that pushes asample proximally using a saline wash. Samples remain spaced apartwithin the needle such that the sequence of their collection ispreserved. Samples can also be removed from a port while the needleremains in place. No mechanical transport mechanisms or drives aredisclosed.

U.S. Pat. No. 5,526,822 shows a transport system that uses a cannula andknock-out pin combined with a vacuum source to shuttle a tissue sampleto a multiple-chamber cassette where it is knocked out. The cannula isthen repositioned for another sample. The vacuum source is external. Arevolving sample cassette is also shown. A vent opening in each samplecylinder of the cassette is provided to eject the fluid used totransport the tissue sample. A removable disposable needle-bearingcassette interfaces with rotary and linear drives by means of long gearsand shuttles that cradle the gears. Cutters operate in rotary and linearfashion (a counter-rotating cutters embodiment is included) and thecannula can be rotated to orient the sample opening.

U.S. Pat. No. 6,017,316 shows a transport system similar to U.S. Pat.No. 5,827,822 in which a cutter transports with vacuum assist. Multiplesampling with single insertion is described but not automated multiplesample-handling. The details of a drive system are not disclosed.

U.S. Pat. No. 6,193,673 shows a needle with a durable part and adisposable part. An external cutting cannula rotates and advancesaxially to cut a sample. The tissue cutter is driven axially by a rackand pinion drive which are part of a durable component. A cradleconnects the rack to the cutting cannula.

U.S. Pat. No. 5,944,673 describes a tissue extractor that rotates withina piercing needle to align with any one of multiple receiving portswhile obstructing the remaining ports. The tissue sample is cut byadvancing the cutter and removing by withdrawing the extractor. A vacuumholds the tissue sample in place during the removal of the tissueextractor from the cutter. The cutter rotates as it advances.

It is known to obtain a single sample with a single insertion. However,there are circumstances where there may be a need to obtain more thanone sample. While the known biopsy needle can be re-inserted multipletimes, such technique can cause pain and scarring of the body site.

It is known to leave a marker at the biopsied site. To do so, however, aphysician or healthcare provider would typically need to withdraw thebiopsy needle and insert a different device to leave a marker at thebiopsied site. The additional step with the marker device concurrentwith the tissue sampling may not allow the marker to be deposited at theactual biopsied site, which can lead to inaccurate post-biopsydiagnosis.

There is a need in the art for improved systems for performing multiplesample biopsies, particularly systems that are amenable toself-contained designs and improved techniques for sample extraction andhandling. There is also a need for efficient and precise marker deliverywith minimal trauma.

SUMMARY OF THE INVENTION

The present invention provides for exemplary embodiments of asingle-insertion, multiple sampling biopsy device. The present inventionalso provides for exemplary embodiments of a single-insertion, multiplesampling device with integrated marker release.

In one aspect, a single-insertion, multiple sampling biopsy deviceincludes an outer cannula, a stylet, a sheath and a drive unit. Theouter cannula extends along a longitudinal axis from a proximal end to adistal end, the outer cannula having a cutting end and a second throughport proximal the cutting end. The stylet is disposed in the outercannula and configured to translate along the longitudinal axis towardsthe distal and proximal ends in the outer cannula. The stylet has asecond bulkhead being in fluid communication from a fluid source to thesecond bulkhead. The sheath is disposed between the outer cannula andthe stylet, the sheath configured to translate along the longitudinalaxis towards the distal and proximal ends. The sheath is disposed insidethe outer cannula and configured to translate along the longitudinalaxis towards the distal and proximal ends. The drive unit is coupled tothe outer cannula, to transmit motive force to the cutting tip. Theinner stylet and sheath translate relative to the outer cannula, andeach other, via another drive unit.

In yet another aspect, a method of sampling biological tissue with abiopsy device is provided. The device has four elongated members thattranslate along a longitudinal axis between a distal end and a proximalend. The method comprising: capturing a biological sample in a chamberdefined by two of the sheaths; and translating the two sheaths as asingle unit through the interior first and fourth sheath to deliver thebiological sample from the distal end to the proximal end.

In yet a further aspect, a method of transporting a tissue containingchamber with a biopsy device is provided. The biopsy device has fourelongated members that translate along a longitudinal axis between adistal end and a proximal end. The method can be achieved by: (a)exposing a first aperture of a second sheath, the aperture having achamber defined by a first and second bulkhead, and floor of the secondelongate member; (b) providing a vacuum proximate the aperture; (c)enclosing the aperture of the second sheath with first elongate member;and (d) translating the chamber defined by the first, second, sheathsthrough a substantial portion of the outer cannula to expose the chamberin a proximal aperture formed through the outer cannula.

A preferred embodiment can include a single-insertion, multiple samplingbiopsy device with an outer cannula extending along a longitudinal axisfrom a proximal end to a distal end, the outer cannula having a firstport. A stylet may be provided and disposed in the outer cannula andconfigured to translate along the longitudinal axis towards the distaland proximal ends in the outer cannula, the stylet having a second port.A sheath may be disposed between the outer cannula and the stylet, thesheath configured to translate along the longitudinal axis towards thedistal and proximal ends. A bulkhead may be disposed in the stylet andconfigured to translate with the stylet along the longitudinal axistowards the distal and proximal ends. A drive unit may be coupled to atleast one of the outer cannula, stylet, and sheath to transmit motiveforce to at least one of the outer cannula, stylet, sheath to move atleast the stylet relative to the outer cannula.

The bulkhead may include one or both of vacuum and pressurized fluidsupply in fluid communication with a passage formed through thebulkhead. A fluid passage may be defined by the inner surface of thestylet and the outer surface of bulkhead, the fluid passage in fluidcommunication with one or more of a pressurized fluid supply and vacuumsupply. The sheath may include a plurality of lands and openings thatdefine a rack to engage with a pinion of the drive unit.

The sheath may include a selection mechanism to select between a firstconfiguration where the sheath may be coupled to the stylet to move as asingle unit and a second configuration where the stylet may be uncoupledfrom the sheath so that the sheath may be movable independently of thestylet.

The sheath may enclose the second port of the stylet to define a volumebounded by a rear bulkhead of the tip, the inner surface of the tip andthe bulkhead. The stylet tip may include a marker disposed in the tip,the marker being ejected from the tip in an operative condition of thedevice. The stylet tip may include a marker mounted on the outer surfaceof the tip, the marker being separated from the tip in an operativecondition of the device. The marker can be one or more of a hookedmarker, helical marker and serrated edge marker. The marker can be anannular marker or a split-ring marker.

A preferred embodiment is also a method of sampling biological tissuewith a biopsy device having three elongated members that translate alonga longitudinal axis between a distal end and a proximal end. The methodcan be achieved by: capturing a biological sample in a chamber definedby two of the elongated members; translating the two elongated membersas a single unit through the interior of a third elongated member todeliver the biological sample from the distal end to the proximal end.

A preferred embodiment is also a method of transporting atissue-containing chamber with a biopsy device having four elongatedmembers that extends along a longitudinal axis between a distal end anda proximal end, the method can be achieved by: exposing a first apertureof a first sheath and a second aperture of a second sheath, the secondsheath having a chamber defined by a first bulkhead, a second bulkheadand a floor portion of the second sheath; providing a vacuum proximatethe second aperture; enclosing the second aperture of the second sheathwith a third sheath; and translating the chamber defined by the secondand third sheaths through a substantial portion of a fourth sheath toexpose the chamber in a third aperture formed through the fourth sheath.

A preferred embodiment also provides a single-insertion multiple samplebiopsy device, in which an outer cannula extends along a longitudinalaxis from a proximal end to a distal end. The outer cannula has acutting distal end and a side port arranged proximal to the distal end.A trochar tip is supported by twin longitudinal members that remainsstationary relative to the outer cannula and the two internal retractinglongitudinal members. There is a first sheath within the outer cannula,with a distal beveled end. The sheath is configured to translate along alongitudinal axis between the distal and proximal ends. There is asecond sheath within the outer cannula configured to translate along alongitudinal axis between the distal and proximal ends. The sheath hasdistal and proximal bulkheads that form a tissue accepting port. Theproximal bulkhead also forms a fluid passage in communication with theproximal end. A drive unit translates and revolves the outer cannularelative to the three inner members. Another drive unit translates thefirst and second sheaths relative to the trocar tip assembly and outercannula where the two sheaths can transpose relative to each other in atimed relationship.

A preferred embodiment also provides a single-insertion, biopsy devicethat includes a cannula that has a proximal end, a distal end, anextraction port at the distal end and a recovery position at theproximal end. First and second elongate elements have distal ends thatare movable between the extraction port of the cannula and the recoveryposition of the cannula. The first and second elongate elements are alsomovable with respect to each other to define extraction and closedconfigurations. In the open configuration, the first and second elongateelement distal ends define a recess with an access. The access faces theextraction port. In the closed configuration, the first and secondelongate element distal ends are mutually opposite to surround a volume.A drive unit coupled to the first and second elongate elementsconfigures them between the open configuration and the closedconfigurations and transfers the first and second elongate elementdistal ends from the extraction port to the recovery position.

The drive unit may transfer the first and second elongate element distalends to the recovery position while the first and second elongateelements are in the closed configuration. The cannula may have arecovery port at the recovery position and the drive unit configures thefirst and second elongate elements into the open configuration aftertransferring their distal ends to the recovery position such that thevolume may be open to the recovery port.

According to an embodiment, the invention is a single-insertion,multiple sampling biopsy device having a sheath extending along alongitudinal axis from a proximal end to a distal end. The sheath has asample recess space within it. The sheath is selectively configurable toopen and close the sample recess space. The sheath has a movablebulkhead within it which is located at a distal end of the samplerecess. The sheath has a sample recovery port located proximal of thesample acquisition port. A drive unit is provided which couples to thefirst bulkhead to move it from the distal end of the sheath to thesample recovery port to transport the sample received in the samplerecess to the sample recovery port. According to this embodiment, thetransport system transports multiple samples in this manner under usercontrol without removing the sheath from the host.

Preferably, a second bulkhead is located on a side of the sample recessopposite the first bulkhead. The second bulkhead preferably has a portconnected to a source of vacuum and/or pressurized fluid. Preferably,the second bulkhead is connected to the drive unit to move with thefirst bulkhead. Preferably, also, the sheath contains first and secondelements that move independently in distal and proximal directionsrelative to the sheath. Here, the directions are collinear with an axisof the sheath, and the first and second elements form respective partsof a cylindrical conduit connected at a proximal end to a vacuum sourceand connected at a distal end to the sample recess.

Preferably, the sheath is directly adjacent the first and secondindependently movable elements where the sheath holds the first andsecond independently movable elements in alignment. In an embodiment,the first and second independently movable elements are hemicylinders.

Also, preferably, there is a selective engagement device and the sheathcontains first and second elements that move independently in distal andproximal directions, where the directions are collinear with an axis ofthe sheath. In this embodiment, the selective engagement deviceinterconnects the first and second elements, the drive unit beingconnected to move one of the first and second elements and to move theother of the first and second elements selectively depending on whetherthe engagement device is engaged to interconnect the first and secondelements.

In an embodiment, the first bulkhead is connected to one of the firstand second elements. In another embodiment, the sheath has a selectionmechanism to select between a first configuration where the sheath iscoupled to the stylet to move as a single unit and a secondconfiguration where the stylet is uncoupled from the sheath so that thesheath is movable independently of the stylet.

In all the above embodiments, a cutting tip extends distally of a distalterminus of the sheath where the cutting tip is connected to one of thefirst and second elements.

In another variation of the base embodiment, a selective engagementdevice is provided. The sheath contains first, second, and thirdelements, the first and second of which move independently in distal andproximal directions. The directions are collinear with an axis of thesheath and the third element is parallel and substantially coextensivewith the first and second elements along an axis of the sheath. In thiscase, the third element has a cutting tip extending distally of a distalterminus of the sheath.

Preferably, the tip includes a marker mounted on the outer surface ofthe tip, the marker being separated from the tip in an operativecondition of the device. The marker is preferably one or more of ahooked marker, helical marker and serrated edge marker.

According to an embodiment, the invention is a method of samplingbiological tissue with a biopsy device having first and second elongatemembers that translate within a third elongate along a longitudinal axisbetween a distal end and a proximal end, the method can be achieved by:capturing a biological sample in a chamber defined between the first andsecond elongated members, translating the first and second elongatemembers. According to another embodiment, the invention is a single unitthrough the interior of the third elongate member to deliver thebiological sample from the distal end of the third elongate member tothe proximal end of the third elongate member. Preferably, the methodincludes translating the first and second elongated members through thethird elongated member in a reverse direction to repeat the capture andtranslation of another sample. Also preferably, the method includescutting the sample from a host by translating the third elongate memberrelative to the first and second elongate members, the third elongatemember having a cutting edge at a distal end thereof that effects thecutting.

According to an embodiment, the invention is a method of transporting atissue-containing chamber with a biopsy device having four elongatedmembers that extends along a longitudinal axis between a distal end anda proximal end, the method can be achieved by: exposing a first apertureof a first sheath and a second aperture of a second sheath, the secondsheath having a chamber defined by a first bulkhead, a second bulkheadand a floor portion of the second sheath, providing a vacuum proximatethe second aperture, enclosing the second aperture of the second sheathwith a third sheath, and translating the chamber defined by the secondand third sheaths through a substantial portion of a fourth sheath toexpose the chamber in a third aperture formed through the fourth sheath.

According to another embodiment, the invention is a single-insertion,multiple sampling biopsy device with an outer cannula extending along alongitudinal axis from a proximal end to a distal end, the outer cannulahaving a cutting distal end and a side port arranged proximal of thedistal end. A cutting tip supported by twin longitudinal members remainsstationary relative to the outer cannula, and the two internalretracting longitudinal members. A first sheath within the outercannula, with a distal beveled end, translates in the distal andproximal directions. A second sheath within the outer cannula isconfigured to translate along a longitudinal axis between the distal andproximal ends. The sheath has distal and proximal bulkheads that form atissue accepting recess, the proximal bulkhead also forming a fluidpassage in communication with the proximal end. A drive unit translatesand revolve the outer cannula relative to the three inner members. Thedrive unit translates the first and second sheaths relative to thecutting tip and outer cannula where the two sheaths can translaterelative to each other in a predetermined relationship.

According to another embodiment, the invention is a single-insertion,biopsy device with a cannula that has a proximal end, a distal end, anextraction position at the distal end and a recovery opening at theproximal end. There are first and second elongate elements with distalends that are movable between the extraction position of the cannula andthe recovery opening of the cannula. The first and second elongateelements are also movable with respect to each other to defineextraction and closed configurations. In the extraction configuration,the first and second elongate element distal ends define a recess at theextraction position. This recess has an access. In the closedconfiguration, the first and second elongate element distal ends aremutually opposite to surround a volume. A drive unit coupled to thefirst and second elongate elements configures them between the openconfiguration and the closed configuration. The drive unit alsotransfers the first and second elongate element distal ends from theextraction position to the recovery opening. Preferably, the drive unittransfers the first and second elongate element distal ends to therecovery opening after placing the first and second elongate elements inthe closed configuration. Also, preferably, the drive unit configuresthe first and second elongate elements into the open configuration aftertransferring their distal ends to the recovery opening. The cannulapreferably has a cutting edge at its distal end and the drive unit movesthe cannula to place the cutting edge over the recess at the extractionposition.

In another embodiment, the invention is a method of taking a biopsytissue sample including receiving a sample in a stylet, held within acutting cannula, while the stylet and cutting cannula are inserted in ahost, and moving the stylet, relative to the cutting cannula, repeatedlyfrom a sample receiving position to a sample recovery position, whilemaintaining the cutting cannula in place within the host. Preferably,the stylet has a cutting tip affixed thereto such that the cutting tipis moved with the stylet. Also, preferably, the receiving operationincludes receiving the sample adjacent a bulkhead affixed to the styletso that the bulkhead pushes the sample as the stylet is moved.

In a variation of the embodiment, the method includes applying a vacuumto the stylet where the sample is received and cutting the sample freeof the host. Preferably, the method also includes extending a cover overthe sample before moving the stylet relative to the cutting cannula. Theextending can include axially moving an elongate member relative to thestylet and the cutting cannula, the elongate member forming a portion ofa cylinder with a major portion of the stylet, the cylinder beingcoaxially arranged within the cutting cannula. In another variation, themethod includes deploying a tissue marker from a tip of the stylet.

According to another embodiment, the invention is a method of taking abiopsy tissue sample. The method includes receiving a sample in astylet, held within a cutting cannula, while the stylet and cuttingcannula are inserted in a host; and extending a cover over the sampleand moving the stylet relative to the cutting cannula from a samplereceiving position to a sample recovery position, while maintaining thecutting cannula in place within the host.

Preferably, the receiving and extending operations are done repeatedlyto recover multiple samples. The stylet preferably has a cutting tipaffixed thereto such that the cutting tip is moved with the stylet.Preferably the receiving operation includes receiving the sampleadjacent a bulkhead affixed to the stylet, the bulkhead pushing thesample as the stylet is moved. Preferably, a vacuum is applied to thestylet where the sample is received and cutting the sample free of thehost. The extending preferably includes axially moving an elongatemember relative to the stylet and the cutting cannula, the elongatemember forming a portion of a cylinder with a major portion of thestylet, the cylinder being coaxially arranged within the cuttingcannula. In a refined embodiment, the method includes deploying a tissuemarker from a tip of the stylet.

According to another embodiment, the invention is a biopsy device, witha stylet that has a sample recess at a distal end and a cannula withsample acquisition port and a sample recovery port. The stylet ismovable within the cannula to move its sample recess from the sampleacquisition port to the sample recovery port. A cover member is movablerelative to the stylet to cover the sample recess selectively. Atransport mechanism is connected to move the stylet and cover. Thetransport mechanism covers the sample recess when a sample is receivedthereat and moving the sample recess such that a sample in the samplerecess is prevented from rubbing against the cannula. The transportmechanism moves the cover to uncover the sample recess to recover thesample when the sample is moved to the recovery port.

Preferably, the sample recess is only partially uncovered at therecovery port while the transport mechanism conveys fluid under pressureto the sample recess to eject the sample. Also preferably, the stylethas a cutting tip affixed thereto such that the cutting tip is movedwith the stylet. The transport mechanism preferably creates a vacuum inthe stylet sample recess to urge tissue into it and moves the cannularelative to the sample recess to cut a sample.

According to another embodiment, the invention is a method of taking abiopsy tissue sample. The method includes covering a sample with a covermember in a sample recess while moving the recess within a cannula, toprevent the sample from frictionally engaging the cannula and partiallyuncovering the sample recess at a sample recovery position whileinjecting fluid under pressure to remove the sample from the samplerecess.

In all of the above devices, a vacuum source and a power source may beprovided in a self-contained hand-held biopsy device. In all of themethods, a biopsy unit may contain a controller programmed to executethe methods automatically or contingent on consecutive command beingentered through the biopsy device.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate presently preferred exemplaryembodiments of the invention, and, together with the general descriptiongiven above and the detailed description given below, serve to explainfeatures of the invention.

FIG. 1 illustrates a perspective view of a biopsy cutter and transportsubassembly according to one exemplary embodiment of the presentinvention.

FIGS. 2A-2G illustrate an exemplary embodiment of ancillary componentsfor the biopsy cutter and transport assembly of FIG. 1.

FIGS. 3A-3H and 3J-3M illustrate a sequence of biopsy tissue extractionof the device of FIG. 2A.

FIGS. 4A-4H illustrate a sequence of biopsy tissue extraction using avariation of the device of FIG. 2A.

FIGS. 5A-5H, 5J and 5K illustrate a sequence of biopsy tissue extractionusing yet another variation of the device of FIG. 1.

FIGS. 6A-6G illustrate an integrated biopsy marking system for each ofthe devices of FIGS. 1-5.

FIGS. 7A-7D illustrate another integrated biopsy marking system for thedevices of FIGS. 1-5.

FIGS. 8A1, 8A2, 8A3, 8B, and 8C illustrate a further integrated biopsymarking system for each of the devices of FIGS. 1-5.

FIGS. 9A and 9B illustrate yet another integrated biopsy marking systemfor each of the devices of FIGS. 1-5.

FIGS. 10 and 11 illustrate components of a drive mechanism for a biopsyneedle having a disposable part and a durable part which mate to createan operable device.

FIGS. 12A and 12B illustrate an alternative embodiment of a cuttingcannula, stylet and sheath.

FIG. 13 illustrates a controller.

DETAILED DESCRIPTION OF THE PREFERRED EXEMPLARY EMBODIMENTS

FIGS. 1-12B illustrate the preferred exemplary embodiments which utilizethe same reference numeral to indicate generally similar components. Inparticular, FIG. 1 is a perspective view of a single-insertion, multiplesamples biopsy device 100 provided with a transport subassembly 200 anda biopsy needle 101. Visible in FIG. 1 is a cylindrical outer cuttingcannula 20 that has a proximal sample recovery port 20A which providesaccess to a channel 10B defined between a sheath 12 and a stylet 10.Cutting cannula 20 has a distal sample acquisition port 20B (see FIGS.3A and 3D). The sheath 12 and the stylet 10 are shaped likehalf-cylinders arranged in mirror-image fashion to surround the channel10B. The sheath 12 and the stylet 10 are surrounded, and held in place,by the cutting cannula 20.

Referring now also to FIGS. 2A through 4H, the transport subassembly 200drives the stylet 10 and the sheath 12. The stylet 10 carries a stylettip 11, which is preferably shaped for insertion into a host, forexample, a trocar. There is a first bulkhead 11A at the rear end of thestylet tip 11. A second bulkhead 14A or 14B, which may be a cylindricalelement with a hole (14A) or a D-shaped element (14B) acts as amechanical barrier, but allows fluid to pass through it. The firstbulkhead 11A and second bulkhead 14A or 14B together define a sampleacquisition recess 10A between them. The cutting cannula 20 extends overa substantial length of the stylet 10, covering the sample acquisitionrecess 10A when fully extended toward the distal end of the stylet 10.

Ancillary components of the device 100 such as respective saline andvacuum reservoirs, motor drive, reduction gears, switches and sensors(not shown) can be coupled to the sample recess 10A through thetransport subassembly 200. The sheath 12 can be provided with a fluidconduit 110 (shown in FIGS. 3G to 3L) to convey air through apressurized or negative pressure (i.e., vacuum) source. In addition, orin the alternative, the second bulkhead 14A or 14B can be in fluidcommunication with a bio-compatible fluid such as, for example, saline.A passage 14C (shown in FIG. 4E and corresponding to the second bulkhead14A embodiment of FIG. 4A) or 14D (shown in FIG. 3A and corresponding tothe second bulkhead embodiment 14B of FIGS. 4A through 4H) opens to thesample acquisition recess 10A and allows a fluid, such as air or saline,to pass through the passage 14C or 14D into the sample acquisitionrecess 10A or 14C or 14D. Alternatively air or fluid can be pumped outof the sample acquisition recess 10A through the passage 14C or 14D.Additional passages can be provided in the second bulkhead withrespective conduits, similar to conduit 110, provided to connect them toa fluid conveyance mechanism.

Focusing for now on FIGS. 3G TO 3L, the conduit 110 may be a flexiblepolymer tube, such as of polyvinyl chloride (PVC) commonly used inmedical equipment. In the embodiment, the conduit 110 terminates in aboss 99 that fits snugly in the channel 10B and is attached to thestylet 10. In an embodiment in which the sheath 12 has a rack portion12B with openings cutting through the sheath, the boss 99 is preferablylocated distally of that rack portion 12B so that the channel 10B,defined by the sheath 12 and stylet 10, is substantially sealed betweenthe boss 99 and the bulkhead 14A. The bulkhead 14A is similarly attachedto the stylet. Suction applied to the conduit 110 draws air from thechannel 10B out through the opening 14D and out from the sampleacquisition recess 10A. Air or other fluids can be conveyed in theopposite direction, under pressure, through the conduit 110 and into thesample acquisition recess 10A.

In alternative embodiments, the bulkhead 14A can be replaced in thisembodiment by the D-shaped bulkhead 14B. The bulkhead 14A and the boss99 can also be replaced by an extension of the conduit 110 that runsright up to the sample acquisition recess 10A forming a bulkhead withits distal end. The boss 99 can be located proximally of a rack portion12C without permitting a leak if the rack portion 12C is formed by aclosed toothed pattern on the sheath 12 as illustrated in FIG. 3M.

In the transport subassembly 200, the rack portion 12B, 12C, both ofwhich are indicated generically by reference numeral 18, engages apinion 16 proximate the sample recovery port 20A. Referring to FIGS. 2Athrough 2E, the use of the pinion 16 and rack 18 with the latchingmechanism 21 allows both the sheath element 12 and the stylet 10 to bemoved simultaneously when the latching mechanism 21 is engaged. When thelatching mechanism 21 is disengaged, the sheath element 12 movesrelative to the stylet 10 as the pinion 16 rotates. As shown in FIGS. 2Ato 2E, the sheath element 12 has a hinge 12C with at least one pivotingmember 22 with a distally-located shoulder 12A and a proximally-locatedtab 12B. The pivoting member 22 is moved into an engaged position (up)to connect the stylet 10 to the sheath element 12 and into a disengagedposition (down) to disconnect the stylet 10, thereby allowing the sheathelement to move relative to the stylet.

Referring to FIGS. 2A and 2B, the cutting cannula 20 can be retracted(FIG. 2A) and advanced (FIG. 2B) by a suitable mechanism such as, forexample, the worm drive assembly described in U.S. Patent ApplicationPublication No. 2005/0165328 published on Jul. 28, 2005, which isincorporated by reference in its entirety herein to this application.

Referring to FIGS. 2C through 2G, the pivoting member 22 can be movedinto engaged and disengaged positions by any suitable actuator, forexample a solenoid actuator 67 connected to a glide 66 both of which areattached to a housing. When the glide 66 is in an engagement position,it pushes the pivoting member 22 into the engaged position and holds itwhile permitting the pivoting member 22 to move with the sheath element12 by allowing the pivoting member 22 to slide on it. Preferably, theglide 66 has a low friction surface, such as Nylon.

Referring to FIGS. 3G to 3L, the outer cutting cannula 20 is shown in anextended position for insertion into a host from which a sample is to beobtained. The sheath element 12 is also in the extended positioncovering the sample acquisition recess 10A. A vacuum is applied throughthe conduit 110 causing a vacuum to be generated in the sampleacquisition recess 10A. The cutting cannula 20 and the sheath element 12are then retracted as shown in FIG. 3H. For this operation, the sheathelement 12 is disconnected from the stylet 10 by disengaging the latchmechanism 22 so that the stylet can remain in place as the sheathelement 12 is retracted. The sheath element 12 may be retracted beforethe cutting cannula 20, or simultaneously with the cutting cannula 20.When the sample acquisition recess 10A is exposed to the host 103, thevacuum causes tissue from the host 103 to be drawn into the sampleacquisition recess 10A. External pressure may also be applied at thispoint, for example manually by the user. The cutting cannula 20 is thenextended as shown in FIG. 3J, severing a tissue sample BSM from the host103. Next, as shown in FIG. 3K, the sheath element 12 is advanced sothat its distal end covers the sample acquisition recess 10A. The latchmechanism 21 is then engaged locking the sheath element 12 to the stylet10 so that when the sheath element is again retracted, as shown in FIG.3L, the stylet 10 is also retracted. The cutting cannula 20 stays inposition relative to the host 103.

Note that the extension of the sheath element 12 so that its distal endcovers the sample acquisition recess 10A is a beneficial feature of theembodiments here and elsewhere in the present disclosure. By coveringthe sample acquisition recess 10A, the sample is prevented fromfrictionally engaging the cutting cannula as the stylet and cover aremoved proximally. This helps to ensure sample integrity. Also, thesheath element helps to reduce the outlet area for ejection of thesample as discussed elsewhere.

FIGS. 3A to 3F show the biopsy needle operations just described in aperspective view. In FIG. 3A, the cutting cannula 20 is retracted,exposing the sample acquisition recess 10A within the stylet 10. Thesample acquisition recess 10A has an internal volume defined by thesecond bulkhead 14A, the first bulkhead 11A, and the inside surface ofthe stylet 10 and cutting cannula 20 (when closed). The vacuum is causedby sucking air through the passages 14D (or 14C in the alternativeembodiment) causing the biological tissue sample BSM to be deposited inthe sample acquisition recess 10A, shown here in FIG. 3B.

For a 14 gauge stylet or needle, the internal volume is sufficient tocapture a mass of at least 50 milligrams of biological tissues, e.g.,turkey breast tissues used in testing. For a 10 gauge stylet 10, theinternal volume is sufficient to capture a mass of at least 150milligrams or more of biological tissues, e.g., turkey breast tissues.The length of the stylet 10 can be of any suitable lengths, such as, forexample, about 250 to about 300 millimeters. The volume V of the housingcontaining all of the components of the device 100 is preferably 500cubic centimeters or less and preferably about 320 cubic centimeterswith particularly preferable dimensions of about 40 millimeters by about40 millimeters and about 200 millimeters. As used herein, the term“about” or “approximately” for any numerical values indicates a suitabledimensional tolerance that allows the part or collection of componentsto function for its intended purpose as a biopsy cutter, biopsy systemor the combination of both the system and cutter.

Once the cutting cannula 20 extends proximate the rear bulkhead 11A ofthe stylet tip 11 to sever the biological tissue BSM, as shown in FIG.3B, the sheath element 12 can be extended distally to completelysurround the tissue sample (FIG. 3C). The cutting action by the cuttingcannula 20 can be by translation, rotation, translation and rotation ora combination of these movements along with back and forth axialmovements of the cutting cannula 20 as part of the cutting strategy.FIG. 3E shows the cutting cannula 20 in its preferred stationaryposition with the stylet 10, stylet tip 11, and the sheath element 12retracted. The sample acquisition recess 10A is retracted until it isaligned with the sample recovery port 20A where bio-compatible liquid26, fluid 28, or air can be used to expel the sample BSM from the samplerecovery port 20A, shown here in FIG. 3F, into a receptacle (not shown).The device 100 is then ready to move towards the initial position inFIG. 3A to take another sample.

An alternative device to obtain a tissue sample or multiple tissuesamples can be seen with reference to FIGS. 4A-4H. In this embodiment,the second bulkhead 14B is not provided with a hollow fluid passage 14D.Instead, the second bulkhead 14B is formed with a D-shaped cross-sectionso that a fluid passage 14C can be formed between the inner surface ofthe stylet 10 and the longitudinal outer surface of the second bulkhead14B. While it is preferable that the second bulkhead 14B is fixed inrelation to the stylet 10, the second bulkhead 14B can be configured tomove for other purposes, such as, for example, adjusting the samplingvolume. As shown in FIG. 4A, vacuum can be provided via passage 14C todraw the biological tissue into the sample acquisition recess 10A. Thecutting cannula 20 can be translated or both translated and rotated tosever the tissue sample BSM from the main mass of biological tissue M(FIG. 4B). The sheath 12 can be extended via the rack and pinionmechanism to enclose the biological tissue BSM for transport towards thesample recovery port 20A (FIG. 4C) while maintaining the outer cannulagenerally at a fixed location (FIG. 4D). It should be noted that avolume to contain the sample is defined by the bulkhead 11A of the tip,the inner surface 11B of the stylet tip 11, the inner surface of thesheath 12 and the second bulkhead 14B.

Referring to FIGS. 5A-5K, in another alternative embodiment, the stylettip 11 of an alternate stylet 13 is stationary while the sheath 12 witha distal beveled end 12D and stylet 10 are translated along at least onestylet rail 13A. This embodiment serves to reduce the possibility ofbiological tissue being drawn into the interior of the cutting cannula20 as would be the tendency in the embodiment of FIG. 3D as the stylet10 is retracted proximally. In this embodiment, the second bulkhead 15is provided with first port 15A and the cutting cannula 20 is provided,as in the previous embodiments, with the sample recovery port 20A. Thestylet tip 11 is attached to a stylet rail 13A which remains fixedrelative to a drive system (not shown here), while the cutting cannula20, sheath element 12, and stylet 13 move relative to it. The drivesystem may be similar to transport subassembly 200 described above. Thestylet 13, the cutting cannula 20, and the sheath element 12 move as inthe previous embodiment, but the stylet rail 13A remains fixed to keepthe stylet tip 11 in a fixed location relative to the host.

The sampling sequence is as follows. In FIG. 5A, the cutting cannula 20is translated or rotated or a combination of both proximally to exposethe port 15A of the stylet 10 and bulkhead 15. Vacuum can be providedthrough passage 15B to draw the tissue sample into the port 15A. Toseparate a tissue sample from the host, the outer cannula is moveddistally as shown in FIG. 5B. Thereafter, the sheath 12 is advanced overthe port 15A to enclose the sample and the sample transported alongstylet rails 13A towards the sample recovery port 20A, shown here inFIGS. 5C, 5D, and 5E. The sequence of tissue sampling is also shown in aside view in FIG. 5F for clarity. In the preferred embodiments, thereare two rails but three, four or more rails can be used as needed forstructural rigidity. FIG. 5K shows the section A-A indicated in FIG. 5Afor clarification of the relationship between the elements discussedabove.

The examples shown in the illustrations and described in detail abovecan be integrated with one or more of four exemplary marking systems. Inparticular, each of four marking systems can be integrated with each ofthe examples described above to provide for at least eight differentintegrated biopsy cutter and marking systems. For clarity, only the fourmarking systems will be described and shown below. However, it should beclear that each marking system can be combined with another of thebiopsy cutter systems as appropriate to arrive at a suitable combinationof biopsy sampling device and integrated marker.

In the foregoing embodiments, the sheath element 12 and stylet 10, 13,and stylet rail 13A can be made of materials and thicknesses withinsufficient strength to be entirely self-supporting. This is becausethe cutting cannula 20 closely surrounds and helps to support theseelements. So the cutting cannula 20 can help to support these elements.Also, these elements also act together, held in close alignment by thecutting cannula 20 so that they can better resist any tendency to betwisted by the cutting cannula 20 as it rotates.

Referring to FIGS. 6A-6G, a marking system utilizing a hook type marker40 (i.e., a “harpoon”) to prevent migration of the marker 40 once it hasbeen deployed, is shown. The hook type marker 40 with hook 42 or 44 canbe deployed in sequence or simultaneously with the sampling of biopsytissues with the various technologies described in relation to FIGS. 1-5above. As shown in FIGS. 6A and 6E, a member (e.g., an internal D-Rod14A, 14B, or the cutting cannula 20) can be used to eject a marker 40stored in the stylet tip 11. In the exemplary embodiment of FIGS. 6A-6G,a second bulkhead 14B is provided with a cut-out portion 14B1 having aramp 14B2 formed on a distal end of the rod 14B. The ramp 14B2 can beused (depending on whether the cutting cannula 20 or rod 14B is axiallytranslated only, rotated only or a combination of axial translation androtation) to ensure that the marker 40 is deposited sufficiently nearthe tissue sampling site. Various marker configurations can be utilized.For example, as shown in FIG. 6D, a marker with wire like hooks 40,square sectioned hook 40B, or marker with serrated edges 40C can be usedin this system.

Referring FIGS. 7A-7D, a marking system utilizing a split ring marker 50can be utilized with various biopsy techniques described above inrelation to FIGS. 1-5. In FIGS. 7A and 7B, the split-ring marker 50 canbe mounted to the stylet 10 via a suitable technique such as, forexample, crimping, swaging or semi-permanent bonding. Optionally, anintermediate member 38 that forms a seal with the cannula or cuttingcannula 20 can be provided to maintain a generally constant outerdiameter of the cutting cannula 20 without an abrupt transition to thestylet tip 11. Referring to FIGS. 7C and 7D, the split-ring marker 50can be deployed by itself, simultaneously with the sampling of thetissue, prior to sampling or subsequent to the sampling. As shown inFIGS. 7C and 7D, the stylet tip 11 can be actuated proximally towardsthe user to force the split-ring marker 50 to detach from the stylet tip11. Alternatively, the cutting cannula 20 can be actuated distally awayfrom the user to force the split-ring marker 50 to separate from thestylet tip 11.

Referring to FIGS. 8A1, 8A2, 8A3, 8B, and 8C, a marking system using ablossom-type marker 60 can be utilized with various biopsy techniquesdescribed above in relation to FIGS. 1 and 2. As shown in FIGS. 8A1-8A3,in perspective, and in 8B and 8C in section, the blossom marker 60 ismounted on a specially configured stylet tip 111 (FIG. 6C), which hasgrooves 112 and ramps 114 disposed about a longitudinal axis of thestylet tip 111. The blossom marker 60 can be mounted by a suitabletechnique, such as, for example, crimping, swaging, or casting onto thespecially configured stylet tip 111. The cutting cannula 20 can be moveddistally away from the user to force the blossom marker 60 to beseparated from the stylet tip 110. As the marker 60 is separated fromthe stylet tip 111, the ramps 114 on the stylet tip 111 force thesectioned tips 62A-62E to blossom, thereby forming hooks 64A-64E.Alternatively, the stylet tip 111 can be moved proximally towards theuser so that the marker is deployed by pushing against the cuttingcannula 20.

Referring to FIGS. 9A and 9B, another marking system is shown which usesa spiral-type marker 70 in conjunction with various biopsy systemsdescribed above in relation to FIGS. 1-5. As shown in FIG. 9A, a coiledmarker wire 70 can be disposed in an interior hollow section 113 of thestylet tip 11. A suitable deployment mechanism can be used to eject thecoiled marker wire out of its storage space in the stylet tip 11. Thedeployment mechanism can be a suitable mechanism, such as, for example,a linear-to-rotary motion converter that converts a linear motion into arotary motion to rotatably expel the marker. For example, the shuttle14A can have a notch at its distal end that engages with the marker wire70 and rotates it.

The materials suitable for use as part of each marker can be, forexample, stainless steel, gold, titanium, platinum, tantalum, bariumsulfate, biodegradable iron or shape memory polymer or metal alloy suchas Nitinol. It is noted that Nitinol is radio-opaque, ultrasonicallyopaque and MRI compatible and therefore would be preferred by itself orin combination with other materials described herein and as known tothose skilled in the art. Further, the markers can be of any suitablesize so that it can be fitted onto a 7, 8, 9, 10, 11, 12, 14, or 16gauge needle.

Although the markers have been shown as a single deployment marker, someof the embodiments disclosed herein can be utilized in a multipledeployment aspect. For example, the stylet tip 11 can be configured tostore a plurality of harpoon markers 40; the stylet 10 can be mountedwith a longitudinal series of split-ring markers 50; the stylet tip 11can be configured with a cutter so that multiple helical markers 70 canbe deployed.

FIGS. 10 and 11 show an alternative embodiment of a drive system fordriving the cutting cannula 20, the sheath 12 and the stylet 10 of theabove embodiments as well as other embodiments. The assembly 201 and 251consists of a disposable component 201 carrying a cutting cannula 20, astylet 10 within the cutting cannula 20, which carries a trocar tip 211.The stylet 10 has a port 210A. The assembly 201 and 251 is illustratedsuch that only the drive components are shown, and a durable component251. Although not shown in the figure, the disposable component 201 mayinclude components such as a sample chamber, fluid circuits forconveying saline and a vacuum, and other elements which may beidentified with the above descriptions of embodiments of biopsy devicesand their operation.

According to one embodiment, a cutter extension 220 forms an axialextension to the cutting cannula 20 and surrounds an upper half-pipe 242and a lower half-pipe 224. The upper half-pipe is an axial extension ofsheath 12 and the lower half-pipe is an axial extension of the stylet10. The three: cutter extension 220, lower half-pipe 224 and upperhalf-pipe 424 are independently movable, in an axial direction, withrespect to each other. In this and other embodiments, the half-pipes canbe replaced with other partial cylindrical or prism sections capable ofproviding mating sections. For example, a ¾ pipe could be made with a ¼pipe. In addition, the longitudinal members could overlap such that themating pairs define a complete (circular) section but the sum of thecircumferential extent of their cross-sections can be greater than afull circle.

The upper half-pipe 224 and the lower half-pipe 242 are driven byrespective lead screws 206 and 208, which rotate in the chassis 218; thelead screw 206 driving the upper half-pipe 224 and the lead screw 208driving the lower half-pipe 242. The lead screws 206 and 208 thread intotraveling carriages 210 and 212, respectively.

The carriage 210 engages a journal 228 affixed to the end of upperhalf-pipe 224 so that when the lead screw 206 turns, the carriage 210moves axially causing the upper half-pipe 224 to move axially with it.Similarly, the carriage 212 engages a journal 226 affixed to the end oflower half-pipe 242 so that when the lead screw 208 turns, the carriage212 moves axially causing the upper half-pipe 242 to move axially withit.

The lead screw 208 has a lead screw gear 202 affixed to an end thereoffor driving the lead screw 208. Similarly, the lead screw 206 has a leadscrew gear 204 affixed to an end thereof for driving the lead screw 206.The cutter extension 220 is driven axially by a cutter screw 214 whichis rotated by a cutter gear 215. The cutter screw 214 is threaded in anut which is affixed to a disposable chassis 218.

The lead screw gear 202 engages a pinion 252 in the durable component251. The lead screw gear 204 engages a pinion 254 in the durablecomponent 251. The cutter gear 215 engages a pinion 256 in the durablecomponent 251. Motor/transmission drives 264, 256 and 260 are connectedto rotate pinions 252, 254, and 256, respectively. The lead screw gears202 and 204 and the cutter gear 215 engage the pinions 252, 254, and 256when the disposable component 201 is attached to the durable component251 with the durable component and the disposable chassis 218registering the various components.

Referring now also to FIGS. 4A to 4D, it should be clear from the abovedescription that when the lead screw gears 202 and 204 and the cuttergear 215 engage the pinions 252, 254, and 256, respectively, the cuttingcannula 20, the sheath 12, and the stylet 10, can be moved independentlyby controlling the motor/transmission drives 260, 256 and 264,respectively. Therefore, the above embodiment permits a sample to betaken into the sample port 210A, in accord with the embodiment of FIGS.4A to 4D and moved to a chamber port 244 in the cutter extension whereit can be recovered.

A controller (not shown) may be configured to control themotor/transmission drives 260, 256 and 264 such that the followingoperation sequence can be realized to obtaining a sample and deliver itto the port 244. Note that the port 244 corresponds, in this embodiment,to the sample recovery port 20A or sample acquisition recess 10A of theembodiments of FIGS. 3A to 4D as described above. The procedure may beas follows.

-   -   1. Upon insertion of the disposable component 201, assert home        position in which the cutting cannula 20 and the stylet 10 are        fully extended toward the needle distal end and sheath 12 is        retracted to the position shown in FIG. 4A. This is done by        running motor transmission drives 260, 256 and 264 to        registration positions, where respective (limit) switches are        triggered, and counting the pulses of respective encoders. The        indication of insertion may be by means of a switch (not shown)        on the durable component 251 triggered by a boss (not shown) on        the chassis 218. The registration may be followed by the        retraction of the chassis 218 in preparation for a thrusting        operation as is known for biopsy needles.    -   2. Upon receipt of a command (e.g., a control panel switch) to        obtain a sample, a vacuum pump (not shown, but preferably a        component such as a syringe is provided in the disposable        component 201 and a mating drive is provided in the durable        component 251) is operated to obtain an initial vacuum.    -   3. As soon an initial vacuum is generated, the cutting cannula        20 is retracted by running motor/transmission drive 260 while        counting pulses of an encoder to a proximal stop point.        Alternatively control signaling can be provided by a limit        switch.    -   4. After a programmed interval, following the retraction of the        cutting cannula 20, the cutting cannula 20 is driven distally by        operating the motor/transmission drive 260 while counting pulses        of an encoder to a proximal stop point. Alternatively control        signaling can be provided by a limit switch.    -   5. At the same time as the cutting operation, the sheath 12 may        be driven distally so that it covers and protects the sample        from frictional engagement with the surrounding surfaces (e.g.,        the cannula 20) when the stylet 10 and sheath 12 are moved        proximally. The sheath 12 may be driven distally at a later        time. The sheath 12 may be driven by operating the        motor/transmission drive 256 while counting pulses of an encoder        to a distal stop point or according to signals of a limit        switch.    -   6. At this point, the sample is covered by the sheath 12 and        stylet 10 may be retracted to the port 244. This may be done by        operating the motor/transmission drives 256 and 264        simultaneously while counting pulses of an encoder to a distal        stop point or according to signals of a limit switch. Preferably        the rotation of the drives is synchronized to keep the sheath 12        and stylet 10 together as they travel to the port 244.    -   7. After the sample reaches the port 244, the sheath 12 may be        further retracted to uncover the sample for extraction through        the port 244. The sample may be ejected as described above, for        example using a puff of air or saline or both.    -   In the present embodiment, the upper and lower half-pipes 242        and 224 are equal-diameter hemi-cylindrical elements that slide        within cutter extension 220, which defines a full cylinder.        However, other arrangements are possible, such as one in which        all three, upper and lower half-pipes 242 and 224 and the cutter        extension 220 define full cylinders which are arranged        coaxially, or where upper and lower half-pipes 242 and 224 are        replaced by rods which are connected to the sheath 12 and stylet        10 toward the distal end of the stylet 10.

FIGS. 12A and 12B illustrate an alternative embodiment of a cuttingcannula 320, stylet 310 and sheath 312 which may be implemented with acoaxial arrangement of the cutting cannula 320, stylet 310 and sheath312 whose functions are similar to cutting cannula 20, stylet 10 andsheath 12 but where instead of the sheath 12 being positioned over thesample by displacing it in an axial direction, the sheath 312 is rotatedabout a common axis of the assembly. In FIG. 12A, the arrangement isshown with the sheath 312 in position for receiving or ejecting a sampleor for cutting. In FIG. 12B, the arrangement is shown with the sheath312 in position for transporting the sample through the cutting cannula320.

Referring to FIG. 13, in all of the above embodiments, various motors,drives, valves, and other actuators are variously described along withtheir respective operations and operational sequences. It is clear fromthe particulars of each embodiment that a device may employ a controller350 such as a programmable microprocessor controller, to provide thedescribed functionality.

While the present invention has been disclosed with reference to certainpreferred embodiments, numerous modifications, alterations, and changesto the described embodiments are possible without departing from thesphere and scope of the present invention, which is described, by way ofexample, in the appended numbered paragraphs below. Accordingly, it isintended that the present invention not be limited to the describedembodiments, but that it have the full scope defined by the language ofat least the following paragraphs, and equivalents thereof.

1-58. (canceled)
 59. A single-insertion, multiple sampling biopsy devicefor insertion into a host, comprising: an outer cutting cannula havingan inner lumen and extending along a longitudinal axis from a proximalend to a distal end, the outer cutting cannula having a cutting distalend, the outer cutting cannula having a proximal sample receiving port,the configured to translate in a proximal direction and a distaldirection; a stylet extending along the longitudinal axis, the styletextends at least partially within the inner lumen of the outer cuttingcannula, the stylet configured to translate in the proximal directionand the distal direction; a sheath extending along the longitudinalaxis, the sheath extends at least partially within the inner lumen ofthe outer cutting cannula, the sheath configured to translate in theproximal direction and the distal direction; a stylet tip attached to astylet rail, the stylet tip extends in the distal direction beyond thedistal end of the outer cutting cannula, the stylet rail extends alongthe longitudinal axis; and a drive unit configured to translate theouter cutting cannula, the sheath, and the stylet relative to the stylettip, the stylet rail remains stationary relative to the drive unit. 60.The single-insertion, multiple sampling biopsy device of claim 59,wherein the stylet rail is disposed between the stylet and the sheath.61. The single-insertion, multiple sampling biopsy device of claim 59,wherein the stylet rail extends at least partially within the outercutting cannula.
 62. The single-insertion, multiple sampling biopsydevice of claim 59, wherein the sheath comprises a beveled distal end.63. The single-insertion, multiple sampling biopsy device of claim 59,wherein the sheath is configured to translate along the stylet rail. 64.The single-insertion, multiple sampling biopsy device of claim 59,further comprising a second stylet rail.
 65. The single-insertion,multiple sampling biopsy device of claim 59, further comprising: abulkhead having a bulkhead distal end, a bulkhead proximal end, a lengththat extends from the bulkhead distal end to the bulkhead proximal end,and a vacuum passage extending along the longitudinal axis through thelength of the bulkhead.
 66. The single-insertion, multiple samplingbiopsy device of claim 65, wherein the bulkhead is disposed inside thestylet.
 67. The single-insertion, multiple sampling biopsy device ofclaim 66, wherein, collectively, the stylet tip, the stylet, and thebulkhead are configured to form a longitudinal port.
 68. Thesingle-insertion, multiple sampling biopsy device of claim 67, whereinthe drive unit is configured to translate and rotate the outer cuttingcannula to expose the longitudinal port.
 69. The single-insertion,multiple sampling biopsy device of claim 67, wherein the drive unit isconfigured to distally advance the sheath to enclose the longitudinalport.
 70. A single-insertion, multiple sampling biopsy device forinsertion into a host, comprising: an outer cutting cannula having aninner lumen and extending along a longitudinal axis from a proximal endto a distal end, the outer cutting cannula having a cutting distal end,the outer cutting cannula having a proximal sample receiving port, theconfigured to translate in a proximal direction and a distal direction;a stylet extending along the longitudinal axis, the stylet extends atleast partially within the inner lumen of the outer cutting cannula, thestylet configured to translate in the proximal direction and the distaldirection; a sheath extending along the longitudinal axis, the sheathextends at least partially within the inner lumen of the outer cuttingcannula, the sheath configured to translate in the proximal directionand the distal direction; a first stylet rail; a second stylet rail; astylet tip attached to the first stylet rail and the second stylet rail,the stylet tip extends in the distal direction beyond the distal end ofthe outer cutting cannula, the first stylet rail and the second styletrail extends along the longitudinal axis; and a drive unit configured totranslate the outer cutting cannula, the sheath, and the stylet relativeto the stylet tip, the first stylet rail, and the second stylet rail,wherein the stylet tip, the first stylet rail, and the second styletrail are stationary relative to the drive unit.
 71. Thesingle-insertion, multiple sampling biopsy device of claim 70, whereinthe first stylet rail is disposed between the stylet and the sheath andthe second stylet rail is disposed between the stylet and the sheath.72. The single-insertion, multiple sampling biopsy device of claim 70,wherein the first and second stylet rails extend at least partiallywithin the outer cutting cannula.
 73. The single-insertion, multiplesampling biopsy device of claim 70, wherein the sheath is configured totranslate along the first and second stylet rails.
 74. Thesingle-insertion, multiple sampling biopsy device of claim 70, furthercomprising: a bulkhead having a bulkhead distal end, a bulkhead proximalend, a length that extends from the bulkhead distal end to the bulkheadproximal end, and a vacuum passage extending along the longitudinal axisthrough the length of the bulkhead.
 75. The single-insertion, multiplesampling biopsy device of claim 74, wherein the bulkhead is disposedinside the stylet.
 76. The single-insertion, multiple sampling biopsydevice of claim 74, wherein a combination of the stylet tip, the stylet,and the bulkhead forms a longitudinal port.
 77. The single-insertion,multiple sampling biopsy device of claim 76, wherein the drive unit isconfigured to translate and rotate the outer cutting cannula to exposethe longitudinal port.
 78. The single-insertion, multiple samplingbiopsy device of claim 76, wherein the drive unit is configured todistally advance the sheath to enclose the longitudinal port.